MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,04 report with the FDA on 2015-04-23 for POLIGRIP ULTRA manufactured by Glaxosmithkline Dungarvan Ltd..
[15235588]
Indigestion. Ill [unwell]. Felt light passing out [felt faint]. Faint. Couldn't stand for too long [ill-defined disorder]. Allergy. Product complaint. Case description: this case was reported by a consumer and described the occurrence of indigestion in a female patient who received gsk denture adhesive (formulation unk) (poligrip ultra) cream (batch number ww8v, expiry date 12/31/2017) for drug use for unknown indication. Concurrent medical conditions included diabetes. On an unknown date, the patient started poligrip ultra. In (b)(6) 2015, an unknown time after starting poligrip ultra, the patient experienced indigestion. On (b)(6) 2015, the patient experienced unwell, felt faint, faint and ill-defined disorder. In 2015, the patient experienced allergy. On an unknown date, the patient experienced product complaint. On (b)(6) 2015, the outcome of the indigestion, unwell, felt faint and faint were recovered/resolved. On an unknown date, the outcome of the ill-defined disorder, allergy and product complaint were unknown. It was unknown if the reporter considered the indigestion, unwell, felt faint, faint, ill-defined disorder and allergy to be related to polgrip ultra. Additional details: the patient had been using poligrip for a long time and opened a new tube of the suspected product "about two weeks ago". On (b)(6) 2015 the patient "felt terribly, terribly ill" and felt she "was going to pass out". The consumer also stated that she "felt faint" and she "can't stand up for too long". The consumer also reported "it definitely caused an allergy, i'm pretty sure". When asked if the symptoms had resolved, the caller stated "i'm feeling alright today" and that she had stopped use of this product from (b)(6)2015. The reporter stated that "maybe it is the mint flavor in the product". Follow up information received on 04/01/2015: qa analysis revealed the complaint to be unsubstantiated.
Patient Sequence No: 1, Text Type: D, B5
[15367871]
Summary of investigation: the batch documentation specific to this lot was retrieved and reviewed and there were no issues noted during the manufacture of this batch. No other complaints of this nature have been received for this lot. A retain sample was requested and sent to the lab for analysis, see results below (protocol: (b)(4)): test: description (visual). Specification: a reddish pink mass of gums and petrolatum, free of lumps, granular particles or foreign matter. Results: complies. Test: ph (420-010). Specification: 6. 5 to 7. 5. Results: 6. 6. Testing was carried out on the retain sample and results were within specification indicating that the product was satisfactory for use. The batch documentation was checked before release and found to be satisfactory. Conclusion: please be assured that this complaint has been logged, will be indicated in the manufacturing site metrics and all be brought to the attention of all relevant site personnel as part of the monthly complaint review process. On the basis of the above i now wish to consider this complaint closed - please revert should you require any further information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681138-2015-00015 |
| MDR Report Key | 4730386 |
| Report Source | 00,01,04 |
| Date Received | 2015-04-23 |
| Date of Report | 2015-03-05 |
| Date of Event | 2015-02-01 |
| Date Mfgr Received | 2015-04-01 |
| Date Added to Maude | 2015-06-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | PO BOX 13398 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Manufacturer G1 | GSK |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLIGRIP ULTRA |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOL |
| Date Received | 2015-04-23 |
| Lot Number | WW8V |
| Device Expiration Date | 2017-12-31 |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLAXOSMITHKLINE DUNGARVAN LTD. |
| Manufacturer Address | DUNGARVAN EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-23 |